FDA 510(k) Applications for Medical Device:
Prosthesis, Elbow, Hemi-, Radial, Polymer
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K041858 | ACUMED LLC |
5885 NW CORNELIUS PASS RD. | HILLSBORO | OR | 97124-9432 |
| K131845 | ACUMED LLC |
5885 NW CORNELIUS PASS RD. | HILLSBORO | OR | 97124-9432 |
| K032686 | ASCENSION ORTHOPEDICS, INC. |
8200 CAMERON RD., SUITE C-140 | AUSTIN | TX | 78754-3832 |
| K023604 | AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A | SAN DIEGO | CA | 92121 |
| K002644 | AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A | SAN DIEGO | CA | 92121 |
| K011819 | AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A | SAN DIEGO | CA | 92121 |
| K982288 | AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A | SAN DIEGO | CA | 92121 |
| K051385 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K012551 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K040611 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K233592 | BioPoly, LLC |
7136 Gettysburg Pike | Fort Wayne | IN | 46804 |
| K000658 | DEPUY ORTHOPAEDICS, INC. |
P.O. BOX 988 | WARSAW | IN | 46581-0988 |
| K213563 | DePuy Synthes |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K001385 | HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K183618 | Ignite Orthopedics, Inc. |
210 North Buffalo Street | Warsaw, | IN | 46580 |
| K132735 | IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME |
2710 DISCOVERY DRIVE, STE 600 | ORLANDO | FL | 32826 |
| K984290 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K192754 | In2Bones USA, LLC |
6000 Poplar Ave, Suite 115 | Memphis | TN | 38119 |
| K212872 | In2Bones USA, LLC |
6000 Poplar Ave, Suite 115 | Memphis | TN | 38119 |
| K030237 | KAPP SURGICAL INSTRUMENT, INC. |
4919 WARRENSVILLE CENTER RD. | CLEVELAND | OH | 44128 |
| K032806 | KINETIKOS MEDICAL, INC. |
6005 HIDDEN VALLEY RD, STE 180 | CARLSBAD | CA | 92011 |
| K231188 | Skeletal Dynamics Inc |
7300 North Kendall Drive | Miami | FL | 33156 |
| K092721 | SKELETAL DYNAMICS, LLC |
80 SHELDON TECHNOLOGY CENTER | SHELTON | CT | 06484 |
| K172688 | Skeletal Dynamics, LLC |
8905 SW 87 Avenue, Suite 201 | Miami | FL | 33176 |
| K062898 | SMALL BONE INNOVATIONS INC. |
505 PARK AVE., 14TH FLOOR | NEW YORK | NY | 10022 |
| K992220 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K112030 | SYNTHES USA, LLC |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K994041 | TORNIER, INC. |
200 GREGORY LN. | PLEASANT HILL | CA | 94523-3389 |
| K030384 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K060731 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K991915 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
